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Non‐Biological Complex Drugs

News

FDA approves 40 mg follow-on version of glatiramer acetate posted 09/03/2018

Sandoz, the generics division of Novartis, announced on 13 February 2018 the approval of its 40 mg follow-on version of...

Research

Biosimilars and follow-on NBCDs for MS in Europe, the US and Canada posted 19/01/2018

The advent of biological medicines has significantly transformed the landscapes of many disease spaces and improved the lives...

Guidelines

FDA issues final guidance on liposome drug products posted 27/04/2018

On 4 April 2018, the US Food and Drug Administration (FDA) issued a new draft guidance document for non-biological complex dr...

Polices & Legislation

FDA to set up abbreviated pathway for complex products posted 21/10/2016

As part of the Generic Drug User Fee Amendments (GDUFA II) reauthorization recently agreed with industry [1], the US Food and...

Reports

Equivalence of complex drug products posted 21/04/2017

Complex drug products and their generic (or follow-on) versions was the subject discussed at the New York Academy of Sciences...